SOURCE: USDM Life Sciences

USDM Life Sciences

May 02, 2014 07:35 ET

USDM Life Sciences Will Be Presenting "Validation of CTMS With Agile Methodology" at BioClinica Global User Conference

SANTA BARBARA, CA--(Marketwired - May 2, 2014) - USDM Life Sciences, a leading global regulatory consulting firm in the life sciences industry, is pleased to announce Diane Gleinser, Vice President of Operations will discuss validation of BioClinica OnPoint CTMS in an agile development environment at the BioClinica Global User Conference. Gleinser is scheduled to speak at 10:40am on Wednesday, May 7th. 

The presentation will include:

  • Validation of BioClinica OnPoint CTMS under agile methodology
  • Pros and cons of using agile methodology
  • CTMS Validation cost savings of 40% - 60% 

"Validation of CTMS can be challenging under any circumstance. The agile methodology is an added complication," said Gleinser. "USDM has developed a validation process and documentation that allows for a less time-intensive and more efficient process." 

Diane Gleinser is the Vice President of Operations for USDM Life Sciences. Gleinser has more than 23 years of experience in life science based industries, encompassing Quality Assurance, Quality Control, Validation and Regulatory Compliance for research and development, clinical affairs, manufacturing and packaging, laboratory setup and analysis, and auditing under cGMP, cGLP and cGCP regulations and 21 CFR Part 11.

As a member of the senior management team at USDM, Gleinser leads a highly skilled team of implementation and compliance engineers, and has been instrumental in establishing USDM's practice groups.

The BioClinica Global User Conference is at the Sheraton Philadelphia Society Hill Hotel in Philadelphia May 5-7.

About USDM Life Sciences:
USDM Life Sciences is a leading global regulatory consulting firm providing compliance, validation, qualification, quality, auditing and information technology services via project teams and staff augmentation to our clients in the medical device, biotechnology, biologics, diagnostics and pharmaceutical industries. USDM Life Sciences has more than 14 years of experience supplying our clients in the life science industry with compliance services during each phase of their drug and product development cycle while partnering with best of breed organizations to help companies simplify, unify and optimize their business and compliance objectives. For more information, please visit

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